NCT04811833

Brief Summary

The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction. This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

March 17, 2021

Last Update Submit

April 3, 2023

Conditions

Gastrointestinal Stromal TumorsGastrointestinal NeoplasmsDigestive System NeoplasmStomach TumorSmall Intestine TumorColon TumorRectum Tumor

Keywords

tumor diseasestomach tumorsmall intestine tumorcolon tumorrectum tumorneed for anastomosis

Outcome Measures

Primary Outcomes (1)

  • Comparison of anastomosis leakage rate at different timepoints in postoperative course

    The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery

    until 6 months after surgery

Secondary Outcomes (18)

  • Comparison of dehiscence rate of the suture line at different timepoints in postoperative course

    at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.

  • Comparison of the Peritonitis rate at different timepoints in postoperative course

    at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery

  • Comparison of the Surgical Site infection rate at different timepoints in postoperative course

    at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery

  • Comparison of bleeding at different timepoints in postoperative course

    at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery

  • Comparison of Abscess at different timepoints in postoperative course

    at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery

  • +13 more secondary outcomes

Study Arms (1)

Monoplus®

Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for ananastomosis.

You may qualify if:

  • Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
  • Age ≥ 18 years
  • ASA ≤ III
  • Written informed consent

You may not qualify if:

  • ASA ≥IV
  • Emergency operations
  • Peritonitis
  • Surgical interventions in the pancreas, oesophagus
  • Patients with traumatic perforations
  • Pregnant and/or breast-feeding women
  • Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks
  • Patients who were receiving immunosuppressant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Parc Taulí Sabadell

Sabadell, Catalonia, 08208, Spain

Location

Servicio de Cirugía General y Digestiva, Sección cirugía

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Gastrointestinal Stromal TumorsGastrointestinal NeoplasmsDigestive System NeoplasmsStomach NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplasms by SiteStomach DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Wenceslao Vasquez Jimenez, Dr.

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 23, 2021

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

ES(2)